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Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners

Primary Purpose

Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
counseling intervention
questionnaire administration
psychosocial assessment and care
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring psychosocial effects of cancer and its treatment, sexual dysfunction, sexuality and reproductive issues, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of primary prostate cancer

    • Advanced or recurrent disease
  • Receiving concurrent hormonal therapy
  • Married and/or co-habitating with a partner for ≥ 1 year
  • T-score > 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner)

PATIENT CHARACTERISTICS:

  • Normal cognitive functioning
  • Able to speak and read English
  • No significant hearing impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Fox Chase Cancer Center - Cheltenham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intimacy-Enhancing Couples Therapy

standard psychosocial care

Arm Description

Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.

Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention

Outcomes

Primary Outcome Measures

Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention
Comparison of the preliminary effect of IECT vs usual care on global psychological distress and relationship intimacy as assessed by the BSI-18 at baseline and at 1 month after completion of study intervention
Relationship functioning, including intimacy, communication, and satisfaction (cancer-specific and overall) as assessed by the CRCS and A-DAS at baseline and at 1 month after completion of study intervention

Secondary Outcome Measures

Full Information

First Posted
June 6, 2007
Last Updated
March 5, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00483678
Brief Title
Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners
Official Title
A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Fox Chase Cancer Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners. PURPOSE: This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners.
Detailed Description
OBJECTIVES: Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with advanced or recurrent prostate cancer and their partners. Compare the effect of IECT vs usual care on patients' and their partners' level of global psychological distress. Compare the effect of IECT vs usual care on relationship intimacy in these participants. OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2 arms. Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention. Arm II: Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction, Sexuality and Reproductive Issues
Keywords
psychosocial effects of cancer and its treatment, sexual dysfunction, sexuality and reproductive issues, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intimacy-Enhancing Couples Therapy
Arm Type
Experimental
Arm Description
Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.
Arm Title
standard psychosocial care
Arm Type
Active Comparator
Arm Description
Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention
Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Primary Outcome Measure Information:
Title
Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention
Time Frame
2 years
Title
Comparison of the preliminary effect of IECT vs usual care on global psychological distress and relationship intimacy as assessed by the BSI-18 at baseline and at 1 month after completion of study intervention
Time Frame
2 years
Title
Relationship functioning, including intimacy, communication, and satisfaction (cancer-specific and overall) as assessed by the CRCS and A-DAS at baseline and at 1 month after completion of study intervention
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of primary prostate cancer Advanced or recurrent disease Receiving concurrent hormonal therapy Married and/or co-habitating with a partner for ≥ 1 year T-score > 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner) PATIENT CHARACTERISTICS: Normal cognitive functioning Able to speak and read English No significant hearing impairment that would preclude study participation PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talia Zaider, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Fox Chase Cancer Center - Cheltenham
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners

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